Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)

April 5, 2017 updated by: Merck Sharp & Dohme LLC

A Multicenter, Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Sitagliptin in Elderly Patients With Type 2 Diabetes Mellitus

To evaluate the effect of treatment with sitagliptin compared to placebo in elderly patients with type 2 diabetes mellitus who have poor glycemic control with diet and exercise.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Community dwelling patients 65 years of age or older diagnosed with Type 2 Diabetes not controlled with diet and exercise
  • Patients must have a HbA1c of 7-10% off medication, or as a result of a protocol wash-out from oral anti-hyperglycemic agents by the qualifying visit

Exclusion Criteria:

  • Patients with type 1 diabetes
  • History of ketoacidosis or requires insulin use
  • Alanine aminotransferase / aspartate aminotransferase > 2.5 X ULN, triglycerides > 600 mg/dL, creatinine clearance < 35 mL/min
  • Fasting plasma glucose consistently > 260 mg/dL
  • Poorly controlled hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Comparator: Placebo
sitagliptin matching placebo for up to a 24-wk treatment period.
Active Comparator: 1
sitagliptin
Drug: sitagliptin phosphate
Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period.
Other Names:
  • MK0431

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24
Time Frame: Baseline and Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
Time Frame: Baseline and Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Baseline and Week 24
Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24
Time Frame: Baseline and Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Baseline and Week 24
Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week
Time Frame: Week 1
Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average.
Week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2006

Primary Completion (Actual)

March 12, 2008

Study Completion (Actual)

March 12, 2008

Study Registration Dates

First Submitted

March 20, 2006

First Submitted That Met QC Criteria

March 20, 2006

First Posted (Estimate)

March 22, 2006

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431-047
  • MK0431-047
  • 2006_003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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